Advanced Heart Failure
Conditions
Interventions
MDT-1118 Ventricular Assist Device
Sponsors
Medtronic Japan Co., Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Must be 20 years of age at consent 2. In judgment of body size, body surface area (BSA) and anatomy by Investigator, patient can be implanted MDT-1118 VAD. 3. Patients with advanced heart failure symptoms (Class IIIB or IV) who are: (patient must meet one of the following) a. On optimal medical management, including dietary salt restriction and diuretics, for at least 45 out of the last 60 days and are failing to respond; or b. In Class III or Class IV heart failure for at least 14 days, and dependent on intra-aortic balloon pump (IABP) for 7 days and/or inotropes for at least 14 days 4. Left ventricular ejection fraction 25% 5. LVAD implant is intended as destination therapy 6. Must be able to receive the MDT-1118 VAD 7. Female patients of childbearing potential must agree to use adequate contraceptive precautions (defined as oral contraceptives, intrauterine devices, surgical contraceptives or a combination of condom and spermicide) for the duration of the study 8. The patient has signed the informed consent form and advance directive 9. The patient and the family understand that destination therapy is end-of-life medical care.
Exclusion criteria
Exclusion criteria: 1Patients with INTERMACS profile 1 2Existence of any ongoing mechanical circulatory support other than an intra-aortic balloon pump 3Prior cardiac transplant 4History of confirmed, untreated abdominal thoracic aortic aneurysm 5 cm, ventricular aneurysm or intraventricular septum rupture 5Severe calcification in thoracic aorta 6Cardiothoracic surgery within 14 days of implantation 7Acute myocardial infarction within 14 days of implant as diagnosed by ST or T wave changes on the ECG, diagnostic biomarkers, ongoing pain and hemodynamic abnormalities as described in the guidelines published in ACCAHA 2007 Guidelines for the Management of Patients with Unstable Angina NonSTElevation Myocardial Infarction1 8Patients eligible for cardiac transplantation 9On ventilator support for 72 hours within the four days immediately prior to implantation 10Pulmonary embolus within 21 days of implantation as documented by computed tomography scan or magnetic resonance imaging (MRI)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is success at 12 months with the following definitions of success and failure Therapy will be considered a success if, at the end of 12 months in the study 1The subject is alive and 2The subject has not had a stroke of Modified Rankin Score 4 and 3The subject retains the originally implanted device, unless the device was removed due to heart recovery, or the patient is electively transplanted. Therapy will be considered a failure if, within the 12 months in the study: 1The subject dies; or 2The subject has a stroke of Modified Rankin Score 4 or 3The device malfunctions or fails, requiring exchange, explantation, or urgent transplantation. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Incidence of all adverse events per INTERMACS definition 2.Incidence of all device failures and device malfunctions per INTERMACS definition 3.Health Status improvement, as measured by KCCQ and EuroQol EQ-5D-5L 4.Functional status improvement, as measured by New York Heart Association (NYHA) classification and 6-minute walk test 5.Overall survival 6. Length of initial hospital stay and incidence and causes of re-hospitalizations, number of hospitalizations, length of extra-hospital stay, length without artificial respirator or continuous IV infusion, purpose of IV infusion 7. Analysis of primary endpoint at 3 months and 6 months | — |
Countries
Japan
Contacts
Public ContactAki Shiomitsu
Medtronic Japan Co., Ltd OU Clinical
Outcome results
None listed